Medical device firm K2M Group Holdings has received 510(k) approval from the US Food and Drug Administration (FDA) to sell its Everest minimally invasive (MI) XT spinal system.
The system has also obtained CE mark approval to market it in the European countries.
K2M Group Holdings president and CEO Eric Major said: "We are excited to receive US regulatory clearance and a CE mark for our Everest minimally invasive XT spinal system, and are pleased with surgeon feedback following the completion of the first surgical cases in the US and Australia.
"Whereas our Serengeti minimally invasive retractor system offers a flexible design, the Everest MI XT system further strengthens our MIS portfolio by offering a rigid design and providing surgeons another innovative minimally invasive option."
Everest is a cannulated top-loading pedicle screw system that features rigid closed-top break-off extension tabs for minimally invasive rod passage.
The implant design of the system provides a one-step true percutaneous delivery of the screw, and built-in extension that does not require intraoperative assembly.
Its closed-top design offers a rigid connection for in-situ rotation of the screw heads, while internal threads of the extension tabs enable for rod reduction.
Everest’s streamlined instrumentation offers surgeons with multiple insertion options in one system, and is comprised of several new designs for simplifying surgical application of the implants, including a simple extension tab removal technique.
The system’s screw features the Everest platform technology that offers a 70° range of polyaxial motion, as well as mixed-metal (Ti/CoCr) head to minimize head splay.